id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2015-N-0648-0071,FDA,FDA-2015-N-0648,"Attachment 1 Comment from U.S. Pharmacopeial Convention Dated October 26, 2015 re Comment from U.S. Pharmacopeil Convention Dated November 12, 2015",Supporting & Related Material,Exhibits,2015-11-20T05:00:00Z,2015,11,,,2015-11-20T21:13:32Z,,0,0,0900006481d60bfd
FDA-2015-N-0648-0005,FDA,FDA-2015-N-0648,Reference 10-2 Celltrion Files for US FDA Approval of Remsima re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-10-29T15:31:05Z,,0,0,0900006481c3f2fc
FDA-2015-N-0648-0013,FDA,FDA-2015-N-0648,Reference 04- Evaluation of Medical Specialty Medications  Utilization and Management Opportunities re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:24:24Z,,0,0,0900006481c3f2f4
FDA-2015-N-0648-0014,FDA,FDA-2015-N-0648,Reference 03- 2010 Specialty Drug Trend Report re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:24:41Z,,0,0,0900006481c3f66c
FDA-2015-N-0648-0008,FDA,FDA-2015-N-0648,Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product Development re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:23:44Z,,0,0,0900006481c3f2f9
FDA-2015-N-0648-0003,FDA,FDA-2015-N-0648,Reference 01- Immunogenicity Assessment for Therapeutic Protein Products re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:22:53Z,,0,0,0900006481c3f66a
FDA-2015-N-0648-0007,FDA,FDA-2015-N-0648,Reference 10- Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Pegfilgrastim re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:23:37Z,,0,0,0900006481c3f2fa
FDA-2015-N-0648-0002,FDA,FDA-2015-N-0648,REFERENCE LIST re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:22:24Z,,0,0,0900006481c3f669
FDA-2015-N-0648-0012,FDA,FDA-2015-N-0648,"Reference 05- Postmarketing Spontaneous Pharmacovigilance Reporting Systems, Chapter 10, in Pharmacoepidemiology, 5th ed re Designation of Official Names and Proper Names for Certain Biological Products",Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:24:13Z,,0,0,0900006481c3f2f5
FDA-2015-N-0648-0011,FDA,FDA-2015-N-0648,Reference 06- Evaluating the Completeness and Accuracy of MedWatch Data re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:24:05Z,,0,0,0900006481c3f2f6
FDA-2015-N-0648-0001,FDA,FDA-2015-N-0648,Designation of Official Names and Proper Names for Certain Biological Products,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2015-08-28T04:00:00Z,2015,8,2015-08-28T04:00:00Z,2015-11-13T04:59:59Z,2015-11-23T22:00:56Z,2015-21382,0,0,0900006481c41306
FDA-2015-N-0648-0010,FDA,FDA-2015-N-0648,Reference 07- ASHP Guidelines on Preventing Medication Errors With Chemotherapy and Biotherapy re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:23:58Z,,0,0,0900006481c3f2f7
FDA-2015-N-0648-0006,FDA,FDA-2015-N-0648,Reference 10-1 Hospira Submits New Biologics License Application to U.S. FDA for Proposed Epoetin Alfa Biosimilar re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:23:29Z,,0,0,0900006481c3f2fb
FDA-2015-N-0648-0015,FDA,FDA-2015-N-0648,Reference 02- Influence of the HLA-DRB1 Genotype on Antibody Development to Interferon Beta in Multiple Sclerosis re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:24:55Z,,0,0,0900006481c3f66b
FDA-2015-N-0648-0004,FDA,FDA-2015-N-0648,Reference 11 - Preliminary Regulatory Impact Analysis re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:23:13Z,,0,0,0900006481c3f2fd
FDA-2015-N-0648-0009,FDA,FDA-2015-N-0648,Reference 08 - StandardOrderSets re Designation of Official Names and Proper Names for Certain Biological Products,Supporting & Related Material,Background Material,2015-08-28T04:00:00Z,2015,8,,,2015-09-01T16:23:51Z,,0,0,0900006481c3f2f8